A Cognitive Bias Modification RCT for Aggression

NCT04819230 | Unknown

• 1 other identifier: 27093
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial will test a computerized cognitive bias modification program (CBM) to treat attention and interpretive biases in patients with primary aggression.

Conditions

Intermittent Explosive Disorder

Outcome Measures

Primary Outcomes (3)

• Change in a Aggression from pretreatment to end of treatment (4 weeks later) and 1-month follow-up

  Overt Aggression Scale-Modified (higher score means more aggression)

  preatment, post-treatment (4 weeks later) and 1-month follow-up. Total of 2 months

• Change in a Anger from pretreatment to end of treatment (4 weeks later) and 1-month follow-up

  State-Trait Anger Expression Inventory-2:state anger scale modified(higher score means more anger)

  pretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 months

• Change in Social Information Processing from pretreatment to end of treatment (4 weeks later) and 1-month follow-up

  Social Information Processing - Attribution and Emotional Response Questionnaire

  pretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 months

Secondary Outcomes (2)

• Change in Emotion Regulation from pretreatment to end of treatment (4 weeks later) and 1-month follow-up

  pretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 months

• Change in IED diagnosis from pretreatment to end of treatment (4 weeks later) and 1-month follow-up

  pretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 months

Study Arms (2)

Bias Modification

EXPERIMENTAL

Attention (ATT) and interpretation (ITT) bias training. Participants complete the ATT and ITT tasks twice per week for four weeks. The ATT trains attention toward neutral stimuli and away from negative stimuli. On trials with one neutral and one threat word, the probe will always follow the location of the neutral word. Therefore, there is a contingency between the valence of the word and the location of the probe. Participants will be asked to indicate which type of probe had appeared in each trial by pressing a corresponding button as rapidly and accurately as possible. The ITT trains participants to make benign (vs. threatening) interpretations of socially-ambiguous scenarios. For each trial, a word suggesting a socially threatening or benign interpretation is presented then replaced by a sentence describing a socially-ambiguous scenario. Participants indicate if they thought the word and sentence were related. Participants will receive corrective feedback after each trial.

Behavioral: Cognitive Bias Modification

Control Condition

PLACEBO COMPARATOR

A combination of attention (ATT-C) and interpretation (ITT-C) control tasks These tasks are identical to the experimental tasks (ATT and ITT) with the exceptions that: ATT-C: It is designed to train attention toward neither neutral nor the threat stimuli. This will be achieved by having an equal number of probes follow the location of the threatening word and the neutral word. ITT-C: It is not designed to train benign interpretations of ambiguous social scenarios. Thus, no feedback will be given during the inter-trial interval, rather participants will see a blank screen between trials. Participants will complete both the ATT-C and ITT-C tasks twice per week for four weeks, totaling to eight experimental sessions.

Behavioral: Cognitive Bias Control

Interventions

Cognitive Bias Modification BEHAVIORAL

A four-week computerized attentional and interpretive bias modification protocol in which participants complete both ATT and ITT tasks twice per week, totaling to eight experimental sessions (see experimental arm for more detail.)

Bias Modification

Cognitive Bias Control BEHAVIORAL

A four-week computerized attentional and interpretive stimuli protocol in which participants complete both ATT-C and ITT-C tasks twice per week, totaling to eight control sessions (see placebo control arm for more detail.)

Control Condition

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Meet DSM-5 criteria for current IED, as assessed via phone screen and confirmed during an in-person diagnostic interview conducted during visit one of the study
• Are able and willing to cooperate with study protocol; i.e. keep appointments, read and understand consent form, etc.
• Have written and verbal English proficiency for understanding consent and study materials

You may not qualify if:

• Have a lifetime history of psychosis
• Have current moderate to severe substance use disorder
• Have a history of bipolar disorder
• Have current major depressive disorder
• Are younger than 18 or older than 55 years old
• Are currently (past month) receiving treatment for anger or aggression
• Recently (past month) started or changed psychotropic medications

Sponsors & Collaborators

• Temple University: lead

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19122, United States

Location

MeSH Terms

Conditions

Disruptive, Impulse Control, and Conduct Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants in the control condition will see the same stimuli with a different contingency for correct vs incorrect response on the computerized training task (participant masking) Outcome assessors will not be involved in administration of the intervention and will not be informed of participant condition (outcomes assessor masking)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 26, 2021
• Study Start: May 1, 2021
• Primary Completion: May 1, 2023
• Study Completion: June 1, 2023
• Last Updated: March 26, 2021

Record last verified: 2021-03

Locations

US (1)